Kornimate/medical-research-clean huggingface dataset:
treatment of mild and subthreshold depressive disorders

Conditions: Depression

Summary: the purpose of this study is to determine the efficacy of a ssri, cognitive-bahavioral-therapy and a free choice between ssri and cbt in a sample of primary care patients suffering from mild to moderate depression. hypotheses: * ssri is superior to placebo * cbt is superior to a non-specific supporting group therapy


Eligibility criteria:
inclusion criteria:(e.g.) * subthreshold and mild depressive disorders including dysthymia (hamd: 8-22) * informed consent * 18 years exclusion criteria:(e.g.) * severe mood disorders * bipolar disorder * recurrent brief depression * suicidality * alcohol or drug dependency * obsessive-compulsive disorder * schizoaffective disorder / schizophrenia * pregnancy

Keywords: depression primary care
effect of using placental membranes on healing and post-op pain after gum surgery

Conditions: Pain, Postoperative; Gingival Diseases

Summary: when harvesting autogenous free grafts to treat periodontal conditions (e.g., lack of attached keratinized tissue, ridge defects, and other mucogingival deformities), the hard palate is the preferred donor site. the primary disadvantage of this technique is the creation of a second surgical site. this sacrificial traumatic lesion on the palate is associated with significant post-operative morbidities, including patient discomfort, infection, inflammation, hemorrhage, and necrosis. a pilot, blinded randomized control trial will be conducted with subjects who are treatment planned to receive free gingival graft palatal harvest surgery. the palatal wound donor site for treatment group 1 will not receive an allograft membrane; while the donor site for treatment group 2 will receive an amnion-chorion allograft membrane (bioxclude) secured with a suture. the severity of pain at the palatal wound site will be assessed using an at home survey (visual analog scale, pain catastrophizing scale, \& patient-reported outcomes measurement information system scale). the healing of the palatal donor site will be evaluated quantitatively and qualitatively (pvs impression, optical scan, endoscopy, and ultrasnonography).


Eligibility criteria:
inclusion criteria: * patients age 18 and above * no reported systemic disease that would compromise healing, such as diabetes with a1c level \>7.0%, endocrine disorders, hypertension above stage ii based on aha 2017, osteoporosis, or immunodeficiency * healthy periodontium or demonstrating stable periodontal condition following conventional periodontal therapy. * clinical indication for periodontal mucogingival surgery utilizing palatal graft harvest e.g., shallow palatal vaults classified by reiser et al. (1996) the average distance as 7 mm from the cej of maxillary teeth to the neurovascular bundle * no history of previous palatal harvesting exclusion criteria: * smoker * pregnancy \[confirmed via patient self-identification\] * systemic condition requiring antibiotic prophylaxis prior to any invasive procedure. the list of such conditions includes: 1. prosthetic cardiac valves, including transcatheter-implanted prostheses and homografts 2. prosthetic material used for cardiac valve repair, such as annuloplasty rings and chords. 3. previous infective endocarditis 4. unrepaired cyanotic congenital heart disease or repaired congenital heart disease, with residual shunts or valvular regurgitation at the site of or adjacent to the site of a prosthetic patch or prosthetic device. 5. cardiac transplant with valve regurgitation due to a structurally abnormal valve. * uncontrolled systemic disease e.g., diabetes with a1c level \> 7.0% endocrine disorders, hypertension above stage ii based on aha 2017, osteoporosis, or immunodeficiency) * use of medications, such as dilantin (aka phenytoin), cyclosporin, and nifedipin, that would adversely affect periodontal tissues

Keywords: grafting; tissue amnion chorion gingival recession wound healing
influence of central sensitization on efficacy of patient-controlled epidural analgesia in osteoarthritis patients undergoing total knee replacement

Conditions: Knee Osteoarthritis

Summary: nociceptor inputs can trigger a prolonged but reversible increase in the excitability and synaptic efficacy of neurons in central nociceptive pathways, the phenomenon of central sensitization. the degenerative joint disease, osteoarthritis, with characteristic destruction of cartilage and alteration in bone is a very common cause of chronic pain. the degree of pain does not always correlate with the extent of joint damage or presence of active inflammation raising the possibility that there may be a central component to the pain. the central sensitization inventory (csi) is a new self-report screening instrument to measure the degree of central sensitization, and to help identify patients with central sensitivity syndromes. the aim of this investigation is to evaluate the influence of preoperative central sensitization, which represented by csi score, on postoperative pain score in osteoarthritis patients undergoing total knee replacement who receiving patient-controlled epidural analgesia.


Eligibility criteria:
inclusion criteria: * aged 20 to 80 years osteoarthritis patients undergoing total knee replacement under spinal anesthesia, and who receiving postoperative epidural pca exclusion criteria: * refusal * coagulopathy * neurologic deficit * preoperative opioids medication * recent analgesics change

Keywords: central sensitization; osteoarthritis; epidural analgesia
questionnaire follow=up study sonia 2

Conditions: Alkaptonuria; Homogentisic Acid; Homogentisate Dioxygenase; Alkaptonuria Severity Score Index

Summary: survey of health of patients completing sonia 2 study: a cross-sectional analysis by questionnaire

the liverpool site will post the once only, short questionnaire (in the correct language using translated documents as appropriate) to the address of those patients who completed sonia 2. hospital approved translation services will be used. a return-addressed stamped envelope for ease of return will also be provided. those who received nitisinone will be sent the nitisinone-administration questionnaire and those who did not receive nitisinone will be sent a no-nitisinone questionnaire

Eligibility criteria:
inclusion criteria: - documented diagnosis of aku. age ≥16 years. exclusion criteria: - not completed sonia 2 study for the full 4-year duration.

Keywords: royal liverpool university hospital
impact of information campaign's alongside maternity staff about bedding infant

Conditions: Sudden Death in Children

Summary: it is now well established that infants should be placed on the back only in a sleepsack without coverage or plush or pillow on a firm mattress in a bedroom. despite these old recommendations of good practice, deviations are observed and some infants are most always lying according to the recommended position. the goal is to assess the impact of an information campaign of staffs maternity of the chu of reims on the practices of the sleeping of infants to motherhood, and then at the home of the parents.

proposal for participation to the holders of parental authority of newborns eligible within 72 hours after the birth of the child. if acceptance of participation, the newborn will be included in the study. participation in the study will not affect the medical care of the child. participation in the study will consist of: a collection of data including the child sleeping mode, complete a questionnaire covering the child sleeping habits to motherhood and home during the 1st month of life. information on the habits of sleeping in the home of the child will be collected via a phone call by an investigator. inclusions will be held over 2 periods: one before and one after the completion of training of health care personnel regarding the sleeping of infants nursing staff training will consist of oral information by the investigative team and written information...

Eligibility criteria:
inclusion criteria: * born in reims chu * parents are 18 years old or more * parents accept their participation in the study exclusion criteria : * hospitalization in urip / kangourou / neonatalogy * needed baby warmer
a study to investigate the effectiveness of tirzepatide (ly3298176) following initiation of ixekizumab (ly2439821) in participants with moderate-to-severe plaque pso and obesity or overweight in clinical practice (together amplify-pso)

Conditions: Psoriasis; Overweight or Obesity

Summary: the main purpose of this study is to assess the effectiveness of adding tirzepatide to ixekizumab therapy in standard clinical practice in participants with moderate-to-severe plaque pso and obesity or overweight with at least 1 weight-related comorbidity. the study will last up to 12 months.


Eligibility criteria:
inclusion criteria: * have a diagnosis of moderate-to-severe plaque pso, as defined by a dermatologist or other experienced clinician treated pso (for example, allergologist, nurse practitioner or physician assistant) * have body mass index (bmi) of 30 kilograms per meter squared (kg/m²) or greater (obesity) or 27 kg/m² to \<30 kg/m² (overweight) in the presence of at least 1 weight-related comorbid condition (hypertension, dyslipidemia, type 2 diabetes mellitus, obstructive sleep apnea, or cardiovascular diseases). * must have initiated treatment with ixekizumab for approximately 3 months (± 1 month) prior to decision to add tirzepatide. * must be able to initiate tirzepatide (day 0) within 30 days of treatment decision (baseline/screening). exclusion criteria: * have currently received ixekizumab for more than 4 months or less than 2 months. * have had any exposure to tirzepatide or other glucagon-like peptide-1 receptor agonist (glp-1 ras), for example, dulaglutide, liraglutide, or semaglutide. * are currently enrolled in any other clinical study. other exclusions * have a known hypersensitivity to tirzepatide or to any of its component. * have a personal or family history of medullary thyroid cancer. * have multiple endocrine neoplasia type 2. * have type i diabetes mellitus. * have a history of chronic or acute pancreatitis at any time before screening (visit 1). * have a history of proliferative diabetic retinopathy, diabetic maculopathy, or nonproliferative diabetic retinopathy that requires acute treatment. * have a history of ketoacidosis or hyperosmolar state/coma. * have a history of severe hypoglycemia and hypoglycemia unawareness within the 6 months before screening. * have a history of severe gastrointestinal complications, including gastroparesis, gastroesophageal reflux disease, dyspepsia, chronic nausea/constipation/vomiting.
mucosal barrier defects in functional dyspepsia by confocal laser endomicroscopy

Conditions: Functional Dyspepsia

Summary: there has been recent interest into the potential role of mucosal barrier defects in the pathophysiology of functional gastrointestinal disorders (fgids). there has been evidence of increased intestinal permeability in patients of ibs,and abnormal tissue resistance in nerd. although the mucosa of functional dyspepsia (fd) patients is endoscopically and histologically "normal," it contains ultrastructural changes, activated immune cells, along with evidence of an increased release of mediators leading to gastric dysfunction. there is now consistent evidence indicating that mucosal barrier defects allow the passage of an increased load of bacteria, antigens and toxins which, in turn evoke activation of mucosal immune responses involved in the fd symptom.

confocal laser endomicrosopy is a newly developed device which allows in vivo and real time observation of gastrointestinal mucosa.in our pilot study we found that the contrast agent fluorescein sodium shew differences of leakage into intercellular spaces and crypt lumen among different patients of fd. this study is aimed to determine if there is microscopic changes detectable in the gastric mucosal epithelium through confocal endomicroscopy of fd patients, and to evaluate the relationship among minimal changes(transmission electron microscopy and confocal laser endomicrosopy ), fd symptoms(symptom index form) , neuropeptides and immune responses(immunohistochemistry).

Eligibility criteria:
inclusion criteria: * patients meeting ibs diagnosis criteria and indications for endoscopy investigation. * asymptomatic individuals for health surveillance or patients for follow up after polypectomy. exclusion criteria: * esophageal, gastric or duodenal cancer or other malignancy * history of esophagus, stomach, or duodenum surgery * conditions that preclude safe biopsies (coagulopathy, haemophilia, esophageal varices,and patients on warfarin and antiplatelets) * a history of bronchial asthma, or known allergy to fluorescein * pregnant or breast-feeding (for females) * below 18 or above 75 years of age * severe co-morbidities * unable or unwilling to give informed consent
novel treatment for syndromic ichthyoses

Conditions: Syndromic Ichthyoses; CHILD Syndrome; Smith Lemli Opitz Syndrome; Conradi Syndrome

Summary: this is an open label-pilot study to assess the efficacy and safety of a novel cholesterol-lovastatin topical solution in children with rare syndromic ichthyoses. often times, these children have difficulty in finding easily applied treatments to make their psoriasiform and ichthyotic plaques more manageable. we propose the use of a cholesterol-lovastatin topical solution as a treatment option with the hypothesis that it will lead to regression of involved areas and decreased erythema and warty-like appearance of the plaques. we plan to enroll children with syndromic ichthyoses over the age of 1 year for a 12 month study with a total of 5 visits and 5 phone calls.


Eligibility criteria:
inclusion criteria: * informed consent form signed by the subject or subject's legal representative; also, if the subject is under the age of majority but capable of providing assent, signed assent from the subject. * diagnosis of a syndromic ichthyoses (verified by dr amy s. paller). * children and adults 12 months of age and above exclusion criteria: * use of any investigational drug within the 30 days before enrollment. * current malignancy. * pregnancy or breastfeeding during the study. (all female subjects of childbearing potential will be assessed for pregnancy at all visits.)
combination therapy of hydroxyurea with l-carnitine and magnesium chloride in thalassemia intermedia

Conditions: β-Thalassemia Intermedia

Summary: the purpose of this study is determination of the efficacy of combination of hydroxyurea with l-carnitine or magnesium in improving hematologic parameters and cardiac status in patients with β-thalassemia intermedia in comparison with hydroxyurea alone .


Eligibility criteria:
inclusion criteria: * beta thalassemia intermedia patients with mean hemoglobin level \>= 7gr/dl, need to blood transfusion with more than 6 months interval or no need to blood transfusion exclusion criteria: * hypothyroidism * hypoparathyroidism * diabetes mellitus * hepatitis b and c * positive tests for human immunodeficiency virus * any cardiac symptoms or receiving drug for cardiac disease * presence of other hemoglobinopathies except thalassemia intermedia and pregnant or lactating womens

Keywords: hydroxyurea magnesium chloride l-carnitine β-thalassemia intermedia
predict-h study: prospective research on essential determinants influencing complication trends in hypospadias - a landmark prospective multicenter cohort study aimed at improving outcome prediction in hypospadias surgery

Conditions: Hypospadias

Summary: hypospadias is a common congenital anomaly with complex anatomy that influences surgical outcomes. despite numerous surgical techniques, a lack of standardized preoperative assessment protocols and consensus on anatomical risk factors limits prediction of complications. this study aims to systematically evaluate key anatomical features identified in previous meta-analyses-such as urethral plate width and length, glans size, chordee severity, meatal position, and others-in a large, prospective multicenter cohort. the ultimate goal is to develop and validate an objective nomogram predicting the risk of postoperative complications, enabling individualized surgical planning and improved patient counseling.


Eligibility criteria:
\* inclusion criteria: male patients aged 1 to 12 years diagnosed with hypospadias (distal, midpenile, proximal) undergoing primary surgical repair parent/legal guardian consent obtained \* exclusion criteria: prior hypospadias or penile surgery (revision cases) major associated genital anomalies (e.g., ambiguous genitalia, severe dsd) refusal of consent or inability to complete follow-up
return to work interventions for patients with low back pain

Conditions: Low Back Pain

Summary: low back pain has become a major concern to employees and employers because of its negative impact on employee health and productivity. the objective of this study is to investigate whether a return-to-work intervention conducted during inpatient rehabilitation improves functional limitations that are related with low back pain and interfere with job performance.

in recent years most industrialized nations have been confronted with a dramatic increase in cases dealing with back pain; in germany, back pain belongs to the major individual and societal health problems with associated costs that have put a strain not only on health care systems. besides frequent demand for medical services, loss of production (due to temporal sick leave) and disability allowances are important economic factors. in total, the estimated annual costs caused by back pain range between 16 and 22 billion euros. population based studies revealed high life-time prevalence with 80% report having ever experienced back pain. the point prevalence lies between 30 and 40%. approximately one-fourth to one-third of those affected suffer from clinically significant back pain. epidemiological evidence for the prevalence of back pain, its severity, course and associated risk factors is extensive; however, little systematic knowledge is available about treatment of back pain especially about return-to-work interventions. this study is designed as a quasi-experimental study to evaluate benefits of return-to-work interventions during medical rehabilitation. positive effects are expected for low back pain related functional limitations and subsequently job performance. the intervention tested is based on the biomechanical model of chronic pain that assumes a relationship between external strain, body posture, muscle activity, and intravertebral pressure. according to this model, chronic low back pain is partially caused by overexertion and poor postural habits. the intervention aims at lowering the impact of biomechanical stress by training an adequate body posture while performing activities of daily living or job-related activities. additionally, performing job-related activities target fear-avoidance beliefs especially assumptions about the connection between pain and work activities. the experimental group training good postural habits while performing activities of daily living or job-related activities (additionally to standard rehabilitation activities such as physiotherapy or education and counselling) will be compared with participants receiving a standard rehabilitation only. outcome measures are assessed at baseline, post-intervention, and 6 month post-intervention.

Eligibility criteria:
inclusion criteria: * chronic low back pain * undergoing inpatient rehabilitation * working age exclusion criteria: * receiving or applying for retirement pension * diagnostic findings that require surgery

Keywords: low back pain; return to work; posture
efficacy and safety of dapagliflozin when added to ongoing metformin and evogliptin combination therapy in patients with type 2 diabetes who have inadequate glycemic control

Conditions: Type 2 Diabetes

Summary: this study evaluates the addition of dapagliflozin in the treatment of type 2 diabetes with metformin and evogliptin combination therapy. half of subjects will receive dapagliflozin, metformin and evogliptin, while the other half will receive placebo, metformin and evogliptin.


Eligibility criteria:
inclusion criteria: 1. patients with type ii diabetes mellitus aged 19 years or older 2. patients who had taken metformin(≥1000mg/day) and dpp(dipeptidyl peptidase)-4 inhibitor combination therapy(or complex is allowed) at the same dose for at least 8 weeks prior to the screening visit 3. patients with fasting plasma glucose≤250mg/dl at the screening visit 4. patients with 18.5kg/m\^2≤bmi≤40kg/m\^2 at the screening visit 5. patients who have signed an informed consent themselves after receiving detailed explanation about the clinical study exclusion criteria: 1. patients with type 1 diabetes, secondary diabetes, gestational diabetes, diabetic coma or -pre-coma, metabolic acidosis including lactic acidosis and diabetic ketoacidosis 2. patients with a medical history of new york heart association(nyha) class iii\~iv heart failure or with congestive heart failure, acute and unstable heart failure 3. patients with severe infectious disease or severe traumatic systemic disorders 4. patients with hypopituitarism or adrenal insufficiency, pulmonary infarction, severe pulmonary dysfunction and other hypoxemia 5. patients with galactose intolerance, lapp lactase deficiency, glucose-galactose malabsorption 6. patients with moderate to severe stage renal disease, end stage renal disease, dialysis at the time of screening visit
least invasive nonlinear light microscopy

Conditions: Oral Leukoplakia; Oral Cancer

Summary: evaluate the ability to image oral mucosa in healthy volunteer by nonlinear microscopy


Eligibility criteria:
inclusion criteria: * health volunteer * patient with suspected oral mucosa lesion exclusion criteria: * active infectious disease * inability to cooperate
gw823093c for the treatment of type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2

Summary: this study was designed to find dose response and as extension in treatment of gw823093c.


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus. * managed by diet therapy or receiving treatment with oral anti-diabetic monotherapy (excluding tzd (thiazolidinediones)) exclusion criteria: * patients who have metabolic disease judged by investigator as a clinically significance * serious cardiovascular disease or serious hepatic disease

Keywords: gw823093c diabetes type 2 diabetes mellitus dpp-iv inhibitor